Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer

Not Applicable

• Conditions: Breast Cancer

• Registration Number: NCT00114296
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

RATIONALE: Chemoprevention is the use of certain drugs or supplements to keep cancer from forming, growing, or coming back. The use of omega-3 fatty acids may prevent breast cancer.

PURPOSE: This randomized clinical trial is studying how well omega-3 fatty acids work in preventing breast cancer in women at high risk of developing breast cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the effects of omega-3 fatty acids on mammographic breast density (MBD) in women at high risk of developing breast cancer.

Secondary

* Determine, preliminarily, the effects of this supplement on cell atypia and breast cell proliferation measured in ductal lavage specimens from these patients.

* Determine the effects of this supplement on circulating hormone and growth factor blood levels in these patients.

* Determine the effects of this supplement on the expression of estrogen-related proteins found in ductal lavage specimens from these patients.

* Determine the effects of this supplement on plasma lipid peroxidation levels in these patients.

* Correlate the modifying effect of lipid peroxidation-related genes with MBD in patients treated with this supplement.

OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral placebo three times daily for 12 months.

* Arm II: Patients receive oral omega-3 fatty acids three times daily for 12 months.

In both arms, treatment continues in the absence of the development of ductal carcinoma in situ or invasive carcinoma of the breast or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-06-13
• Study First Submitted QC: 2005-06-13
• Study First Posted: 2005-06-14
• Status Verified: 2006-07
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breast density as measured by the Madena method at 1 year

Trial Locations

Locations (1)

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States